Orodispersible lozenges containing a combination of Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 and normal gum function: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
Abstract Following an application from BioGaia AB submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Sweden, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the sc...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2020-03-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2020.6004 |
| _version_ | 1831751221353906176 |
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| author | EFSA Panel on Nutrition, Novel foods and Food Allergens (NDA) Dominique Turck Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst John Kearney Helle Katrine Knutsen Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Frank Thies Sophia Tsabouri Marco Vinceti Jean‐Louis Bresson Yolanda Sanz Alfonso Siani |
| author_facet | EFSA Panel on Nutrition, Novel foods and Food Allergens (NDA) Dominique Turck Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst John Kearney Helle Katrine Knutsen Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Frank Thies Sophia Tsabouri Marco Vinceti Jean‐Louis Bresson Yolanda Sanz Alfonso Siani |
| author_sort | EFSA Panel on Nutrition, Novel foods and Food Allergens (NDA) |
| collection | DOAJ |
| description | Abstract Following an application from BioGaia AB submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Sweden, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to orodispersible lozenges containing a combination of Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 and normal gum function. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The Panel considers that orodispersible lozenges containing L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 are sufficiently characterised. Maintenance of normal gum function is a beneficial physiological effect. Out of the two studies from which conclusions could be drawn and that investigated the effect of lozenges containing L. reuteri at the proposed conditions of use (i.e. consumption twice daily) on appropriate gingival outcomes (bleeding on probing (PoB) and gingival index (GI)) in subjects with gingivitis, but without periodontitis, one showed a large effect on BoP and other gingival outcomes and one showed no effect. No effect was found in one study with the use of one lozenge daily. The three studies that investigated, at the proposed conditions of use, modified GI (and not BoP or GI) in subjects with gingivitis, but without periodontitis, or were conducted in patients with periodontitis support an effect of lozenges with L. reuteri on gum function. Some evidence has been provided for mechanisms by which consumption of lozenges containing L. reuteri could improve outcomes of gingivitis in patients with chronic periodontitis but the relevance of such mechanisms for the target population of the claim (i.e. subjects without periodontitis) is unclear. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of orodispersible lozenges containing a combination of L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 and maintenance of normal gum function. |
| first_indexed | 2024-12-21T22:41:01Z |
| format | Article |
| id | doaj.art-4b6f61b9e9344c5e9e39b3eca4779f15 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-21T22:41:01Z |
| publishDate | 2020-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-4b6f61b9e9344c5e9e39b3eca4779f152022-12-21T18:47:50ZengWileyEFSA Journal1831-47322020-03-01183n/an/a10.2903/j.efsa.2020.6004Orodispersible lozenges containing a combination of Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 and normal gum function: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006EFSA Panel on Nutrition, Novel foods and Food Allergens (NDA)Dominique TurckJacqueline CastenmillerStefaan De HenauwKaren Ildico Hirsch‐ErnstJohn KearneyHelle Katrine KnutsenAlexandre MaciukInge MangelsdorfHarry J McArdleAndroniki NaskaCarmen PelaezKristina PentievaFrank ThiesSophia TsabouriMarco VincetiJean‐Louis BressonYolanda SanzAlfonso SianiAbstract Following an application from BioGaia AB submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Sweden, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to orodispersible lozenges containing a combination of Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 and normal gum function. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The Panel considers that orodispersible lozenges containing L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 are sufficiently characterised. Maintenance of normal gum function is a beneficial physiological effect. Out of the two studies from which conclusions could be drawn and that investigated the effect of lozenges containing L. reuteri at the proposed conditions of use (i.e. consumption twice daily) on appropriate gingival outcomes (bleeding on probing (PoB) and gingival index (GI)) in subjects with gingivitis, but without periodontitis, one showed a large effect on BoP and other gingival outcomes and one showed no effect. No effect was found in one study with the use of one lozenge daily. The three studies that investigated, at the proposed conditions of use, modified GI (and not BoP or GI) in subjects with gingivitis, but without periodontitis, or were conducted in patients with periodontitis support an effect of lozenges with L. reuteri on gum function. Some evidence has been provided for mechanisms by which consumption of lozenges containing L. reuteri could improve outcomes of gingivitis in patients with chronic periodontitis but the relevance of such mechanisms for the target population of the claim (i.e. subjects without periodontitis) is unclear. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of orodispersible lozenges containing a combination of L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 and maintenance of normal gum function.https://doi.org/10.2903/j.efsa.2020.6004L. reuteri DSM 17938L. reuteri ATCC PTA 5289gum functiongingivitishealth claim |
| spellingShingle | EFSA Panel on Nutrition, Novel foods and Food Allergens (NDA) Dominique Turck Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst John Kearney Helle Katrine Knutsen Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Frank Thies Sophia Tsabouri Marco Vinceti Jean‐Louis Bresson Yolanda Sanz Alfonso Siani Orodispersible lozenges containing a combination of Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 and normal gum function: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 EFSA Journal L. reuteri DSM 17938 L. reuteri ATCC PTA 5289 gum function gingivitis health claim |
| title | Orodispersible lozenges containing a combination of Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 and normal gum function: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 |
| title_full | Orodispersible lozenges containing a combination of Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 and normal gum function: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 |
| title_fullStr | Orodispersible lozenges containing a combination of Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 and normal gum function: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 |
| title_full_unstemmed | Orodispersible lozenges containing a combination of Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 and normal gum function: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 |
| title_short | Orodispersible lozenges containing a combination of Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 and normal gum function: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 |
| title_sort | orodispersible lozenges containing a combination of lactobacillus reuteri dsm 17938 and lactobacillus reuteri atcc pta 5289 and normal gum function evaluation of a health claim pursuant to article 13 5 of regulation ec no 1924 2006 |
| topic | L. reuteri DSM 17938 L. reuteri ATCC PTA 5289 gum function gingivitis health claim |
| url | https://doi.org/10.2903/j.efsa.2020.6004 |
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